Understanding Treatment Adherence Among Individuals With Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00183495
First received: September 13, 2005
Last updated: January 22, 2010
Last verified: January 2010

September 13, 2005
January 22, 2010
March 2004
March 2007   (final data collection date for primary outcome measure)
Participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence [ Time Frame: Measured three times over 6 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00183495 on ClinicalTrials.gov Archive Site
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Understanding Treatment Adherence Among Individuals With Bipolar Disorder
Determinants and Manifestation of Illness Behavior in Promoting Treatment Adherence Among Individuals With Bipolar Depression

This study will examine how various factors, such as psychiatric symptoms, gender, social support, substance use, and attitudes toward medication, affect treatment adherence in individuals with bipolar disorder.

Bipolar Disorder (BPD), also known as manic-depressive illness, is a disorder that causes frequent shifts in an individual's mood, energy, and ability to function. An individual with BPD may go through periods of mania, which are characterized by increased energy, irritability, and an excessively "high" euphoric mood. The manic periods are followed by periods of depression, which are characterized by decreased energy, feelings of hopelessness, and anxiety. BPD is a persistent and severe mental illness with a high suicide rate; it must be strictly managed through medication and therapy. Many BPD medications have been developed recently; however, there are still many individuals who do not respond well to medication treatment. Research has shown that the way individuals experience illness has an effect on their response to medication. The purpose of this study is to gain insight into how individuals with BPD perceive and respond to medication treatment. Factors such as gender, degree of social support, drug and alcohol usage, and attitudes towards medication will be evaluated to understand how they affect medication and treatment adherence.

This 6-month study will consist of 3 interviews. Each interview will last approximately 2 and ½ hours and will include numerous standardized psychological questionnaires. The questionnaires will assess participants' attitudes toward BPD treatment; psychiatric illness severity, including symptoms of mania and depression; level of addiction to alcohol and drugs; availability of social support resources; and medication adherence.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Individuals with bipolar disorder receiving treatment at a Community Mental Health Clinic in Northeast Ohio.

Bipolar Disorder
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Sajatovic M, Biswas K, Kilbourne AK, Fenn H, Williford W, Bauer MS. Factors associated with prospective long-term treatment adherence among individuals with bipolar disorder. Psychiatr Serv. 2008 Jul;59(7):753-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
August 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of bipolar disorder type I for at least two years prior to study entry
  • Has experienced an index depressive episode
  • Received treatment with medication to stabilize mood for at least 6 months prior to study entry
  • Able to participate in psychiatric interviews
  • Lives in the Northeast Ohio area and is a patient at either Northeast Ohio Health Services or The Mood Disorders Clinic at University Hospitals of Cleveland

Exclusion Criteria:

  • Unable/unwilling to participate in psychiatric interviews
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183495
K23 MH065599-01, DAHBR 9K-TA
No
Martha Sajatovic, MD, Professor of Psychiatry, Case Western Reserve University School of Medicine
National Institute of Mental Health (NIMH)
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Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
National Institute of Mental Health (NIMH)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP